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ID

30266

Description

Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00687297

Lien

https://clinicaltrials.gov/show/NCT00687297

Mots-clés

Versions (1)
  1. 5/25/18 5/25/18 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

May 25, 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Lung Cancer NCT00687297

    Anglais

    Eligibility Lung Cancer NCT00687297

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically or cytologically confirmed non-small cell lung cancer
    Description

    Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    advanced disease (stage iiib disease [malignant pleural or pericardial effusion seen on ct or chest x-ray, any n, m0] or stage iv disease [any t, any n, m1: distant metastases]) that is primary or recurrent
    Description

    Advanced disease TNM clinical staging | Malignant Pleural Effusion CT | Malignant pericardial effusion CT | Malignant Pleural Effusion Chest X-ray | Malignant pericardial effusion Chest X-ray | Primary disorder TNM clinical staging | Recurrent disease TNM clinical staging

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0679246
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C0080032
    UMLS CUI [2,2]
    C0040405
    UMLS CUI [3,1]
    C0220655
    UMLS CUI [3,2]
    C0040405
    UMLS CUI [4,1]
    C0080032
    UMLS CUI [4,2]
    C0039985
    UMLS CUI [5,1]
    C0220655
    UMLS CUI [5,2]
    C0039985
    UMLS CUI [6,1]
    C0277554
    UMLS CUI [6,2]
    C3258246
    UMLS CUI [7,1]
    C0277556
    UMLS CUI [7,2]
    C3258246
    measurable disease according to the recist criteria
    Description

    Measurable Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    ecog performance status 0 or 1
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate organ function, as evidenced by all the following
    Description

    Organ function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    absolute neutrophil count (anc) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
    Description

    Absolute neutrophil count | Platelet Count measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    hemoglobin ≥ 9 gm/dl
    Description

    Hemoglobin measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    total bilirubin ≤ 1 x institutional uln; if patient has gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 x institutional uln.
    Description

    Serum total bilirubin measurement | Gilbert Disease | Hyperbilirubinemia Isolated | Abnormal Liver function tests Absent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0017551
    UMLS CUI [3,1]
    C0020433
    UMLS CUI [3,2]
    C0205409
    UMLS CUI [4,1]
    C0151766
    UMLS CUI [4,2]
    C0332197
    ast, alt and alkaline phosphatase (alk phos) must be ≤ 1.5 uln
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201850
    creatinine ≤ 1.5 x institutional uln or calculated creatinine clearance ≥ 60 ml/min
    Description

    Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C2711451
    potassium between 4 meq/l and institutional uln (supplementation may be used),
    Description

    Serum potassium measurement | Potassium supplementation allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0302353
    UMLS CUI [2,1]
    C0561938
    UMLS CUI [2,2]
    C0683607
    calcium (ionized or adjusted for albumin)within institutional normal limits
    Description

    Calcium ionised normal | Calcium Corrected for albumin Normal

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0855660
    UMLS CUI [2,1]
    C0006675
    UMLS CUI [2,2]
    C1439360
    UMLS CUI [2,3]
    C0205307
    magnesium within institutional normal limits (supplementation may be used)
    Description

    Serum magnesium normal | Magnesium supplementation allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0858145
    UMLS CUI [2,1]
    C1096534
    UMLS CUI [2,2]
    C0683607
    no prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration)
    Description

    Exclusion Criteria | Cytotoxic Chemotherapy Advanced disease | Targeted Therapy Advanced disease | Cytotoxic Chemotherapy Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Prior Adjuvant Therapy Carcinoma of lung allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2,1]
    C0677881
    UMLS CUI [2,2]
    C0679246
    UMLS CUI [3,1]
    C2985566
    UMLS CUI [3,2]
    C0679246
    UMLS CUI [4,1]
    C0677881
    UMLS CUI [4,2]
    C0027627
    UMLS CUI [5,1]
    C2985566
    UMLS CUI [5,2]
    C0027627
    UMLS CUI [6,1]
    C1514456
    UMLS CUI [6,2]
    C0684249
    UMLS CUI [6,3]
    C0683607
    able to take oral medication
    Description

    Able to swallow Oral medication

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0175795
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    myocardial infarction, superior vena caval syndrome, nyha classification of heart disease ≥ 2 within the 3 months prior to entry
    Description

    Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0038833
    UMLS CUI [3,1]
    C0018799
    UMLS CUI [3,2]
    C1275491
    history of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
    Description

    Ventricular arrhythmia Uncontrolled Treatment required for | Ventricular arrhythmia Recurrent Treatment required for | Supraventricular arrhythmia Uncontrolled Treatment required for | Supraventricular arrhythmia Recurrent Treatment required for | Nodal rhythm disorder Uncontrolled Treatment required for | Nodal rhythm disorder Recurrent Treatment required for

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0085612
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C0332121
    UMLS CUI [2,1]
    C0085612
    UMLS CUI [2,2]
    C2945760
    UMLS CUI [2,3]
    C0332121
    UMLS CUI [3,1]
    C0428974
    UMLS CUI [3,2]
    C0205318
    UMLS CUI [3,3]
    C0332121
    UMLS CUI [4,1]
    C0428974
    UMLS CUI [4,2]
    C2945760
    UMLS CUI [4,3]
    C0332121
    UMLS CUI [5,1]
    C0264893
    UMLS CUI [5,2]
    C0205318
    UMLS CUI [5,3]
    C0332121
    UMLS CUI [6,1]
    C0264893
    UMLS CUI [6,2]
    C2945760
    UMLS CUI [6,3]
    C0332121
    hypertension not controlled by medication
    Description

    Uncontrolled hypertension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    peripheral or sensory neuropathy > grade 1
    Description

    Peripheral Neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0031117
    UMLS CUI [1,2]
    C1516728
    UMLS CUI [2,1]
    C0151313
    UMLS CUI [2,2]
    C1516728
    known hypersensitivity to carboplatin or docetaxel
    Description

    Carboplatin allergy | Hypersensitivity Docetaxel

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0570701
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0246415
    active infection
    Description

    Communicable Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    Retour au début de la page

    Similar models

    Eligibility Lung Cancer NCT00687297

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Non-Small Cell Lung Carcinoma
    Item
    histologically or cytologically confirmed non-small cell lung cancer
    boolean
    C0007131 (UMLS CUI [1])
    Advanced disease TNM clinical staging | Malignant Pleural Effusion CT | Malignant pericardial effusion CT | Malignant Pleural Effusion Chest X-ray | Malignant pericardial effusion Chest X-ray | Primary disorder TNM clinical staging | Recurrent disease TNM clinical staging
    Item
    advanced disease (stage iiib disease [malignant pleural or pericardial effusion seen on ct or chest x-ray, any n, m0] or stage iv disease [any t, any n, m1: distant metastases]) that is primary or recurrent
    boolean
    C0679246 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0080032 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    C0220655 (UMLS CUI [3,1])
    C0040405 (UMLS CUI [3,2])
    C0080032 (UMLS CUI [4,1])
    C0039985 (UMLS CUI [4,2])
    C0220655 (UMLS CUI [5,1])
    C0039985 (UMLS CUI [5,2])
    C0277554 (UMLS CUI [6,1])
    C3258246 (UMLS CUI [6,2])
    C0277556 (UMLS CUI [7,1])
    C3258246 (UMLS CUI [7,2])
    Measurable Disease
    Item
    measurable disease according to the recist criteria
    boolean
    C1513041 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Organ function
    Item
    adequate organ function, as evidenced by all the following
    boolean
    C0678852 (UMLS CUI [1])
    Absolute neutrophil count | Platelet Count measurement
    Item
    absolute neutrophil count (anc) ≥ 1500/mm³ and platelet count ≥ 100,000/mm³
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    Hemoglobin measurement
    Item
    hemoglobin ≥ 9 gm/dl
    boolean
    C0518015 (UMLS CUI [1])
    Serum total bilirubin measurement | Gilbert Disease | Hyperbilirubinemia Isolated | Abnormal Liver function tests Absent
    Item
    total bilirubin ≤ 1 x institutional uln; if patient has gilbert's disease, then patient must have isolated hyperbilirubinemia (e.g. no other liver function test abnormality), with maximum bilirubin ≤ 2 x institutional uln.
    boolean
    C1278039 (UMLS CUI [1])
    C0017551 (UMLS CUI [2])
    C0020433 (UMLS CUI [3,1])
    C0205409 (UMLS CUI [3,2])
    C0151766 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
    Item
    ast, alt and alkaline phosphatase (alk phos) must be ≤ 1.5 uln
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201850 (UMLS CUI [3])
    Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    creatinine ≤ 1.5 x institutional uln or calculated creatinine clearance ≥ 60 ml/min
    boolean
    C0201976 (UMLS CUI [1])
    C2711451 (UMLS CUI [2])
    Serum potassium measurement | Potassium supplementation allowed
    Item
    potassium between 4 meq/l and institutional uln (supplementation may be used),
    boolean
    C0302353 (UMLS CUI [1])
    C0561938 (UMLS CUI [2,1])
    C0683607 (UMLS CUI [2,2])
    Calcium ionised normal | Calcium Corrected for albumin Normal
    Item
    calcium (ionized or adjusted for albumin)within institutional normal limits
    boolean
    C0855660 (UMLS CUI [1])
    C0006675 (UMLS CUI [2,1])
    C1439360 (UMLS CUI [2,2])
    C0205307 (UMLS CUI [2,3])
    Serum magnesium normal | Magnesium supplementation allowed
    Item
    magnesium within institutional normal limits (supplementation may be used)
    boolean
    C0858145 (UMLS CUI [1])
    C1096534 (UMLS CUI [2,1])
    C0683607 (UMLS CUI [2,2])
    Exclusion Criteria | Cytotoxic Chemotherapy Advanced disease | Targeted Therapy Advanced disease | Cytotoxic Chemotherapy Neoplasm Metastasis | Targeted Therapy Neoplasm Metastasis | Prior Adjuvant Therapy Carcinoma of lung allowed
    Item
    no prior cytotoxic chemotherapy or targeted therapy for advanced or metastatic disease (prior adjuvant therapy for lung cancer allowed if completed > 1 year prior to registration)
    boolean
    C0680251 (UMLS CUI [1])
    C0677881 (UMLS CUI [2,1])
    C0679246 (UMLS CUI [2,2])
    C2985566 (UMLS CUI [3,1])
    C0679246 (UMLS CUI [3,2])
    C0677881 (UMLS CUI [4,1])
    C0027627 (UMLS CUI [4,2])
    C2985566 (UMLS CUI [5,1])
    C0027627 (UMLS CUI [5,2])
    C1514456 (UMLS CUI [6,1])
    C0684249 (UMLS CUI [6,2])
    C0683607 (UMLS CUI [6,3])
    Able to swallow Oral medication
    Item
    able to take oral medication
    boolean
    C2712086 (UMLS CUI [1,1])
    C0175795 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification
    Item
    myocardial infarction, superior vena caval syndrome, nyha classification of heart disease ≥ 2 within the 3 months prior to entry
    boolean
    C0027051 (UMLS CUI [1])
    C0038833 (UMLS CUI [2])
    C0018799 (UMLS CUI [3,1])
    C1275491 (UMLS CUI [3,2])
    Ventricular arrhythmia Uncontrolled Treatment required for | Ventricular arrhythmia Recurrent Treatment required for | Supraventricular arrhythmia Uncontrolled Treatment required for | Supraventricular arrhythmia Recurrent Treatment required for | Nodal rhythm disorder Uncontrolled Treatment required for | Nodal rhythm disorder Recurrent Treatment required for
    Item
    history of an uncontrolled or recurrent ventricular, supraventricular or nodal arrhythmia that requires treatment
    boolean
    C0085612 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0332121 (UMLS CUI [1,3])
    C0085612 (UMLS CUI [2,1])
    C2945760 (UMLS CUI [2,2])
    C0332121 (UMLS CUI [2,3])
    C0428974 (UMLS CUI [3,1])
    C0205318 (UMLS CUI [3,2])
    C0332121 (UMLS CUI [3,3])
    C0428974 (UMLS CUI [4,1])
    C2945760 (UMLS CUI [4,2])
    C0332121 (UMLS CUI [4,3])
    C0264893 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    C0332121 (UMLS CUI [5,3])
    C0264893 (UMLS CUI [6,1])
    C2945760 (UMLS CUI [6,2])
    C0332121 (UMLS CUI [6,3])
    Uncontrolled hypertension
    Item
    hypertension not controlled by medication
    boolean
    C1868885 (UMLS CUI [1])
    Peripheral Neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades
    Item
    peripheral or sensory neuropathy > grade 1
    boolean
    C0031117 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    C0151313 (UMLS CUI [2,1])
    C1516728 (UMLS CUI [2,2])
    Carboplatin allergy | Hypersensitivity Docetaxel
    Item
    known hypersensitivity to carboplatin or docetaxel
    boolean
    C0570701 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0246415 (UMLS CUI [2,2])
    Communicable Disease
    Item
    active infection
    boolean
    C0009450 (UMLS CUI [1])
    Retour au début de la page 

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